FSMA Final Rule Watch: Whistleblower Protection

The FDA Food Safety Modernization Act (FSMA) added section 1012 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide added protection for employees who “blow the whistle” and come forward with information about potential food safety problems within their companies or facilities.  Although Section 1012 took effect upon FSMA’s enactment in 2011, the Department of Labor (and not FDA) is responsible for enforcing the employee protection provision of the law.  To implement this provision, the Department of Labor’s Occupational Safety and Health Administration (OSHA) issued an interim final rule (IFR) in February 2013 and provided an opportunity for public comment.

On April 18, OSHA issued its final rule to implement the FSMA whistleblower provisions.  Having received responsive comments from only two organizations, OSHA adopted the final rule with only minor revisions to the IFR.  The final rule establishes procedures for employees who seek to file retaliation complaints under FSMA’s whistleblower provision.  The rule also specifies procedures that OSHA and employers must follow when investigating and responding to such complaints, as well as procedures for filing objections to the agency’s findings and for requesting a hearing.  Employees must file retaliation complaints within 180 days of the alleged retaliatory activity, and meritorious complaints may result in employees being entitled to a variety of remedies, such as reinstatement, back pay, and compensatory damages.

The whistleblower provision and OSHA’s final regulations in this area play a key role in implementing FSMA’s prevention-based approach to food safety in the United States.